Comparison of Pelvic Floor Therapy and Yoga on Stres Urinary Incontinence Incontinence

NCT05253898 | Unknown

• 1 other identifier: 2021/005
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of pelvic floor physical therapy (PFT) and therapeutic yoga training (TYT) for women who have postnatal stress urinary incontinence (SUI).

Conditions

Urinary Incontinence; Urinary Tract Disorders

Keywords

Urinary incontinence; Postnatal; Yoga; Pelvic floor muscle; Rehabilitation; Quality of life

Outcome Measures

Primary Outcomes (8)

• İncontinence Questionary at 8 weeks

  İncontinence Questionary-3 (3IQ) is a simple questionnaire to categorize the type of urinary incontinence. First question evaluates the existence of incontinence in the past 3 months. Second and third questions are directed to familiarity and the existence of the types of incontinence. The 3IQ is a quick test to evaluate the types of urinary incontinence with high sensitivity especially for stress urinary incontinence.

  Change from Baseline in incontinence questionary at 8 weeks

• Incontinence Severity Index

  Incontinence Severity Index (ISI) is a tool for assessing the severity of female urinary incontinence. ISI is consists of 2 questions to establish frequency and amount of leakage. The results categorize the severity into 4 as; slight, moderate, severe, and very severe.

  Change from Baseline in Incontinence Severity Index at 8 weeks

• Incontinence Quality of Life

  Incontinence Quality of Life (I-QoL) is used for assessing the decrease of quality of life depending on urinary incontinence symptoms. I-QoL consists of 22 questions and results with 4 domains. I-QoL has identified the 3 factors; avoidance and limiting behavior (8 items), psychosocial impacts (9 items), and social embarrassment (5 items).

  Change from Baseline in Incontinence Quality of Life at 8 weeks

• Global Perception of Improvement

  Global Perception of Improvement (GPI) is used for showing the individual improvement of healing depending patient's perspective. GPI is rated to the satisfaction of advancement depending on the treatment for patients. Patients rated themselves as much better, better, about the same, worse, and much worse.

  Change from Baseline in Global Perception of Improvement at 8 weeks

• Pelvic Floor Muscle Strength assessing with PERFECT

  PERFECT is used to assess pelvic floor muscle power, endurance, maximal repetitions, and the number of fast contractions by using internal digital palpation. (P) symbolizes the power and this value is identified with modified oxford Scale during max. volunteer contraction. (E) symbolizes the endurance and it's identified by how much time will continue the max. volunteer contraction. (R) symbolizes the repetitions and it's identified with the number of maximum volunteer contractions, between each contraction, must be 4 s resting time. (F) symbolizes the fast and it's identified the number of fast contractions. (ECT) symbolizes every contraction time which means recording all numbers and times during evaluation.

  Change from Baseline in PERFECT degrees at 8 weeks

• 1 hour Pad Test

  Pad test is an objective way to scale the amount of incontinence in a specific time and the same conditions. The test begins with drinking 500ml water and 30 minutes sitting, then equal repetitions of jumping, walking, coughing, bending down, and washing hands-on running water for each patient.

  Change from Baseline in Pad Test at 8 weeks

• State-Trait Anxiety Inventory

  State-Trait Anxiety Inventory (STAI) form consist of 2 different tool. STAI-I examines the current anxiety level, and STAI-II examines the aspects of anxiety proneness general states of calmness and confidence. STAI-I consist of 20 questions about how person feel during the test. STAI-II consist of 20 questions about continues anxiety level.

  Change from Baseline in State-Trait Anxiety Inventory at 8 weeks

• Bladder Diary

  Bladder diary is used to asses lower urinary tract symptoms (LUTS).

  Change from Baseline in Bladder Diary at 8 weeks

Study Arms (2)

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

Group 1 includes a training program about correctly using pelvic floor muscles. At the first session, an educational program will be given to all women about the anatomy and function of the pelvic floor muscles. Then, the pelvic floor muscles contractions will be controlled by vaginal palpation for approximately 10 minutes. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of fast and slow pelvic floor muscles contractions in different positions, and 10 minutes of abdominal breathing, general relaxation, stretching, and cool-down exercises. It is planned to teach contractions with internal palpation for 10 minutes before the first session to ensure that the patients' pelvic floor contractions are performed correctly. PFT treatment will be given as two sessions per week, 45 minutes, and 8 weeks as group sessions.

Procedure: Pelvic floor Physical Therapy

Therapeutic Yoga Training

ACTIVE COMPARATOR

Group 2 program includes therapeutic yoga training. It will begin with education about the positive effects of yoga on the body and pelvic floor. Then it will follow with 5 minutes of warm-up exercises, 30 minutes of different asanas coordinated with breathing, and 10 minutes of yogi breathing and cool-down exercises. Also, a home exercise program will be given based on yoga sessions. Participants will receive a detailed description of the home program.

Procedure: Therapeutic Yoga Training

Interventions

Pelvic floor Physical Therapy PROCEDURE

Purpose of pelvic floor muscle education program is reduce the symptoms of stress urinary incontinence and improving quality of life.

Pelvic Floor Physical Therapy

Therapeutic Yoga Training PROCEDURE

Purpose of this group show the effectiveness of yoga therapy on stress urinary incontinence and quality of life.

Therapeutic Yoga Training

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women ages between 18 and 50 years old,
• Women who have SUI 45 days and above after giving birth
• Patients who accept to join the group sessions and will participate regularly in the treatment program

You may not qualify if:

• Women who have pelvic organ prolapsus and fecal incontinence
• Women who have undergone surgery for the lower urinary system
• Those who receive medication treatment for incontinence in the last 3 months
• Those with acute infection and bladder stones or tumors will not be included in the study.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Special Nova Therapy and Rehabilitation Center

Diyarbakır, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urologic Diseases

Condition Hierarchy (Ancestors)

Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysenur Tuncer, PT, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Central Study Contacts

Aysenur Tuncer, PT, PhD

CONTACT

+90-342 2118080; aysenur.tuncer@hku.edu.tr

Nergiz Sayin, PT

CONTACT

nergizsyn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: January 18, 2022
• Primary Completion: June 13, 2022
• Study Completion: August 15, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-01

Locations

TU (1)